Author and oversee deviations, investigations, CAPAs, and related reports to closure within established timelines for the manufacturing department. Support technical operations with Controlled Changes.
Deviation and Investigation Management
Initiate deviations within required timeframes and document immediate actions
Perform impact assessments
Use process knowledge and root cause investigation tools to identify root causes of product and process deviations.
Support documentation of experimental plan, execution, and results to support investigations
Ensure robustness (complete, accurate and defendable) of all critical and major investigations
Author and execute any experiments or runs to support investigations.
Work cross-functionally to assess and analyze deviations and investigations to determine impact
Work cross-functionally to ensure production continues in a compliant manner in the event of a deviation and document accordingly.
Author investigations and support resolution of product complaints, Out Of Expectation, Out Of Specification, Out of Tolerance results
Develop and document effective corrective and preventative actions
Ensure all CAPAs are implemented through GMP systems (e.g. MBR revision, training, CR, etc.) in a timely manner
Monitor and ensure effectiveness checks of CAPAs are conducted
Communicate to the production team any training or awareness events to reinforce quality behaviors.
Develop and initiate Change Requests (CRs)
Manage all phases of a controlled change
Ensure that changes are implemented in a timely and compliant manner
Work with the Engineering/Facility/Metrology and Raw Materials/Supplier Quality/Procurement/Sourcing groups to resolve manufacturing vendor material, manufacturing environment, and equipment related issues.
Escalate deviations according to escalation guidelines.
Provide deviations details (root cause and CAPAs) until the escalation is resolved to the global escalation team.
Quality Events: Owns and manages Quality Events related to GMP manufacturing and or Warehousing
Communicates, escalates, initiates, and owns trend events under the QE module.
Ensure that the required CAPAs are communicated and created in order to eliminate or reduce reoccurrences
Support the site and global C> during self-inspection, audit/inspection readiness and support the backroom if required.
Opening of deviations within required timeframe; Closing of investigations within required timeframe; Effective CAPAs Success rate of internal audits and Health Authorities' inspections.
BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree preferred.
Proven writing skills with technical documents
Fluent in speaking / writing in English
Minimum 5 years’ experience in GMP manufacturing role on the shop floor and/or QA/QC, preferred.